Lanreotide In Polycystic Kidney Disease Study

NCT02127437 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-04-08

No results posted yet for this study

Summary

LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.

An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.

Conditions

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD

Interventions

DRUG

Lanreotide

120 mg, subcutaneously, once every 4 weeks

DRUG

saline

0,5 ml, subcutaneously, once every 4 weeks

Sponsors & Collaborators

  • IPSEN pharmaceutical company, Boulogne-Billancourt, France

    collaborator UNKNOWN
  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Dominique JOLY, MD, PhD · Necker hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-19
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127437 on ClinicalTrials.gov